Engineering Answers / Compliance & Documents
Both regimes end with a document that says the part is safe for food. They get there by different routes, and the documents are not interchangeable.
FDA 21 CFR 177.2600 is a US rule for rubber articles intended for repeated food contact. It works by a positive list of permitted ingredients plus an extraction test in distilled water and n-hexane, with limits expressed per unit area of food-contact surface. LFGB is the German food and feed code; for silicone the operative reference is BfR Recommendation XV, which combines a positive list with sensory evaluation and migration testing. A part can satisfy one and not the other, and neither document substitutes for the other.
Both regimes answer the same question — is this material safe in contact with food — and they answer it from different directions.
The US route is formulation-first. 21 CFR 177.2600 defines rubber articles for repeated use, then lists the substances permitted in them: base polymers, vulcanising agents, accelerators, antioxidants and so on. If an ingredient is not on the list, the material is not covered. On top of that sits an extraction requirement: the finished article is extracted in distilled water and in n-hexane under reflux, and the extractables must stay under limits expressed per unit area of food-contact surface.
The German route is performance-first. LFGB sets the legal frame, and for silicone the operative technical reference is BfR Recommendation XV. It carries its own positive list, then requires the finished article to be evaluated for sensory change — odour and taste transfer — and for migration of constituents. The sensory requirement has no direct equivalent in the US rule, and it is the one that catches a technically compliant part that tastes of rubber.
| Question | FDA 21 CFR 177.2600 | LFGB / BfR XV |
|---|---|---|
| Legal form | Regulation with a positive list | National law plus a technical recommendation |
| Who enforces | FDA, post-market | German competent authorities, post-market |
| Evidence expected | Compound letter of guarantee plus extraction data | Test report from an accredited lab |
| Sensory requirement | None explicit | Odour and taste evaluation required |
| Migration testing | Extraction limits per unit area | Migration of constituents, per protocol |
| Certificate issued by authority | No | No |
| Typical document a buyer receives | Supplier declaration and test data | LFGB test report plus declaration of conformity |
The row that causes the most confusion is the last one. Neither authority issues a certificate. Every "FDA certificate" and every "LFGB certificate" in circulation was written by a supplier or a lab, and its value depends entirely on what is attached to it — the compound identity, the test protocol, the report number and the date.
Silicone is one of the material groups without a harmonised EU measure. Regulation (EC) 1935/2004 sets the general safety requirement, traceability and the declaration of conformity; Regulation (EC) 2023/2006 sets good manufacturing practice. Neither specifies test limits for silicone.
In the absence of a harmonised measure, national rules fill the gap, and BfR XV is the one most European buyers reference. French and Italian national provisions also exist and are used in those markets. That is why a European customer may ask for "LFGB" even when their own country has its own rule: it is the common language, not the only law.
Taste and odour. A peroxide-cured compound can pass the US extraction limits and still fail a sensory panel. If the application is a baby bottle nipple, a coffee lid or a cooking utensil, the sensory result is the one the customer will notice, and it is decided by the cure system rather than by the compound's compliance paperwork.
Colour and additives. Both regimes restrict colorants, and the permitted lists are not identical. A compound formulated for a European customer with a European pigment may need re-formulation for a US customer, and the reverse. This is a compounder question, not a moulder question, but it surfaces at the moulder because that is who the buyer asks.
Repeated versus single use. 177.2600 is written around repeated use. A single-use article may fall under a different provision, and a supplier who applies the repeated-use extraction limits to a single-use part is producing evidence for the wrong clause.
The compound grade and lot, the compounder's letter of guarantee naming the regulation, the extraction or migration test report for that grade, and a declaration from us naming the part number, the material and the intended contact condition. Four documents, all traceable to the parts shipped. If a customer needs a specific lab or a specific national protocol, that is decided at the quotation stage, because re-testing a finished part later costs more than choosing the right test first.
A supplier who can answer those four before quoting is a supplier whose compliance file will survive the first customer audit. One who answers "all our silicone is food grade" has told you nothing that can be checked.
No. The FDA does not approve food-contact materials or issue certificates for them. What exists is a compound whose ingredients are permitted under 21 CFR 177.2600 and which passes the regulation's extraction limits, evidenced by the compounder's letter of guarantee and the moulder's declaration. Anyone offering an "FDA certificate" is offering a document they wrote themselves, which is not the same thing — although in practice that declaration plus the extraction data is what a US customer accepts.
In practice yes, and most food-grade silicone compounds are formulated to satisfy both. The two systems overlap heavily on the positive list, so a compliant compound usually clears both. What differs is the test evidence: LFGB expects sensory evaluation and migration data in the German format, while the US route expects the extraction results against 177.2600. Ask the compounder for both sets at the specification stage rather than after the first order.
No. The declaration under Regulation (EC) 1935/2004 is a statement the business makes about compliance and traceability; it does not itself contain test results. An LFGB or BfR XV test report is laboratory evidence against a specific test protocol. Buyers often ask for the declaration and assume the testing is behind it. Ask for both, and check that the report's date and the compound grade match what you are buying.